MinorEligibility criteria expanded, about 18 words
Secondary endpoints: details revised at 1 of 1 entry
Publications: 57 to 58
2 versionsRe-verified since Nov 11, 2025, no change to tracked fieldsv30-v31
MinorEligibility criteria revisedv29
Re-verified, no change to tracked fieldsv28
NotablePrimary and study completion dates: Jun 2023 to Jun 2028
Enrollment target: 5112 to 5499
Study description shortened, about 14 words
v27
Show 25 earlier versionsHide 25 earlier versions
Re-verified, no change to tracked fieldsv26
MinorStudy sites: 13 to 12v25
MinorStudy description expanded, about 2 wordsv24
MinorStudy description expanded, about 468 wordsv23
Re-verified, no change to tracked fieldsv22
MinorStudy description shortened, about 15 wordsv21
NotablePrimary and study completion dates: Jun 2018 to Jun 2023v20
MinorPrimary completion date: Dec 2017 to Jun 2018v19
2 versionsRe-verified since Aug 18, 2016, no change to tracked fieldsv17-v18
MinorTrial status: Recruiting to Active, Not Recruiting
Site details revised at 13 of 13 sites
v16
MinorStudy sites revised (13)v15
MinorSite details revised at 2 of 13 sitesv14
Re-verified, no change to tracked fieldsv13
MinorSite details revised at 1 of 13 sites
Publications: 9 to 57
v12
NotableTrial status: Active, Not Recruiting to Recruitingv11Show 7 more changesShow less
Enrollment target: 3834 to 5112
Primary completion date: Dec 2017
Study completion date: Jun 2008 to Jun 2018
Eligibility criteria expanded, about 84 words
Study description shortened, about 59 words
Study sites revised (13)
Collaborators revised (7)
NotableLead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to University of Pennsylvania
Collaborators revised (7)
v10
2 versionsRe-verified since Oct 2, 2008, no change to tracked fieldsv8-v9
MinorTrial status: Recruiting to Active, Not Recruitingv7Show 5 more changesShow less
Enrollment target: estimated 3300 to confirmed 3834
Study completion date: Dec 2009 to Jun 2008
Site details revised at 13 of 13 sites
Collaborators expanded, about 25 words
Publications: 7 to 9
3 versionsRe-verified since Sep 5, 2006, no change to tracked fieldsv4-v6
MinorSite contacts updated at 1 of 13 sitesv3
MinorStudy sites: 3 to 13
Study completion date: Dec 2009
Study description expanded, about 307 words
Publications: 6 to 7
v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy.
The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.
Trial Details
NCT Number
NCT00304148
Lead Sponsor
University of Pennsylvania Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Case Western Reserve University, University of Michigan, University of Illinois at Chicago, Tulane University, Kaiser Permanente